Valve For A Surgical Or Medical Instrument

ABSTRACT

A valve for surgical or medical instruments includes a passage that can be at least partially sealed by twisting a flexible section ( 1 ) of the passage wall, an element for rotating a mobile end ( 3 ) of flexible section ( 1 ), characterized in that the actuating element includes a cable for transmitting movement to mobile end ( 3 ) of the flexible section. Also described is a surgical or medical instrument including a valve as detailed.

This invention concerns a valve for surgical or medical instrument aswell as a surgical or medical instrument equipped with the said valve.

The invention will particularly apply to the execution of endovascularintroducers.

However, this field is not exhaustive.

Instruments used as introducers into a patient's body, and in particularfor endovascular, including percutaneous and/or transparietal,interventions require the presence of parts that will ensure that theintroducer creates a seal.

More especially, the invention applies when introducing objects such aselongated surgical guides, balloons and endoprotheses into theinstrument to avoid as far as possible the backflow of blood through theintroducer instrument.

Document U.S. Pat. No. 5,256,150 describes a device for introducingcatheters into a vessel in the patient's body.

This device applies to a large-diameter system with a cylindricaldeformable sheath made of a flexible material that is capable of beingtwisted by the relative rotation of these two ends.

This deformation is induced by rotating one of the ends using a complexdrive system which includes a rack and a system of toothed wheels.

This system does not give entire satisfaction, especially because thesystem used by the operator to transmit the movement to the cylindricalelement which can be twisted is complex and this leads to highmanufacturing costs and a bulky product.

The present invention overcomes entirely or in part the disadvantages ofcurrent devices and presents an alternative to the known means ofactuation.

One of the advantages of the invention is to develop a valve systemwhich is notably less expensive than the existing one and much smaller.

The size of the operating assembly is particularly important as thelarger the system, the less ergonomic it becomes.

According to one embodiment, the configuration of the valve according tothe invention allows it to be operated by an operator using only onehand, the hand which he uses to hold the surgical instrument itself.

According to a preferred variant, the invention also allows smoothrotational movement of a torsionally deformable element.

In addition, the cable drive system proposed according to the preferredembodiment enables the gripping means to be positioned and oriented in avery flexible manner depending on needs in terms of ease of use.

Moreover, the invention can be perfectly adapted to the size of theintroduced element so as to ensure this element forms an excellent seal.

In particular, the system allows the user positioned longitudinallyrelative to the valve to operate the invention.

This produces natural actuation.

The invention concerns a valve for a surgical or medical instrumentcomprising:

a passage that can be at least partially closed by torsional deformationof a flexible section of the passage wall,

means for rotating a mobile end of flexible section in order to generatetorsion, characterized in that the actuation means comprise a cable fortransmitting movement to the mobile end of flexible section.

According to non exhaustive but advantageous variants, this valve issuch that:

-   -   one end of the transmission cable is secured to gripping means        which can be moved by an operator.    -   it comprises an angle drive device to deviate the transmission        cable.    -   the angle drive consists of a pulley.    -   the angle drive and gripping means are arranged so that gripping        means can be moved along the longitudinal axis of the valve.    -   it has means for returning mobile end to the default position.    -   the return means consist of a torsional spring the end of which        is fixed and whose other end acts in rotation with mobile end of        flexible section.    -   the return means are arranged so that the passage of the valve        is closed by default.    -   it includes means for blocking the valve in the open position.    -   the blocking means include a pin blocking the actuating means    -   mobile end acts in rotation with a rotational shaft to which is        fastened one end of the transmission cable.    -   rotary shaft has a groove for fastening and winding up the        transmission cable.    -   It includes an additional cable which, when pulled, is capable        of transmitting a movement to mobile end of flexible section in        the opposite direction to that of the transmission cable.    -   the additional cable is guided by a return pulley and an angle        drive pulley.    -   the mobile end acts in rotation with rotary shaft which has a        groove for fastening and winding up the transmission cable and        an additional groove for fastening and winding up additional        cable.    -   the gripping means move in a slide the edges of which have at        least one row of teeth for retaining a finger assembled        elastically on the gripping means.

This present invention also relates to a medical and surgical instrumentequipped with such a valve.

Other applications and advantages will appear during the description ofa preferred embodiment which follows, but which is not exhaustive.

The attached drawings are given as examples and are not an exhaustiverepresentation of the invention. They represent only one embodiment ofthe invention and will help to make it easily understood.

FIGS. 1 to 3 show the flexible section of the valve in threeconfigurations with torsional mechanical stress:

FIG. 4 is a sectional view B-B of FIG. 5 showing the longitudinalelements comprising the valve.

FIG. 5 is a side view of the invention.

FIGS. 6 to 9 show in turn certain components of the valve subject of theinvention.

Thus, FIG. 6 shows a pulley that can be used as an angle drive.

FIG. 7 shows an example of the valve body configuration.

FIG. 8 shows a possible arrangement of the gripping means.

FIG. 9 shows an embodiment of the rotary shaft in perspective viewshowing more particularly the front and a view showing more particularlythe rear of the shaft.

FIG. 10 is a perspective view of the invention.

FIG. 11 is another embodiment of the invention with a system of twoopposite cables.

FIG. 13 shows a front view of a rotary shaft that can be used in thisembodiment and FIG. 12 a sectional view.

FIG. 14 shows a configuration of a gripping means used to fasten one endof the cables.

A slide for the gripping means in FIG. 14 is shown on FIG. 15.

The valve according to the invention uses the twisting properties of aflexible section 1 of a passage inside the valve.

This passage extends generally along the length of the valve so as toemerge in tube 5, a distal part of which is used for introduction intothe patient's body.

The flexible section such as is shown on FIGS. 1 to 3 is made up of anappreciably hollow cylindrical form made of a tight and flexiblematerial such as silicone.

Section 12 in this case includes two ends 2, 3 with an edge which isthicker than the remainder of flexible section 1 so as to constituteelements joining the flexible section to the other parts.

On FIG. 1, flexible section 1 is not stressed and the central passage isentirely open.

On FIG. 2, an arrow along the valve axis indicates the start of end 3rotation and, therefore, the start of flexible section 1 tending tocreate a constricted zone roughly in the middle of flexible section 1,as show the arrows oriented vertically.

FIG. 3 shows another configuration of flexible section 1 in whichtorsion has continued to be applied so as to completely close thepassage at the centre of flexible section 1.

The means for rotating end 3 of flexible section 1 will now be morepractically explained in greater detail.

It will be noted that the example here executes rotation of end 3.

However, it could be another end.

Moreover, the simultaneous and opposite rotation of two ends 2, 3 is notexcluded by the invention.

FIG. 4 shows a preferred embodiment of the means for rotating end 3 offlexible section 1 using a cable.

On this figure, the passage in the centre of the valve is closed so asto constitute the default position of the system.

On this figure, end 3 of flexible section 1 is turned by default so asto twist flexible section 1.

The operator is able to turn end 3 in the opening direction when it isrequired to introduce an object through the valve.

In the illustrated example, end 3 acts in rotation with a rotary shaft 9shown on FIG. 4 and illustrated in greater detail on FIG. 9.

End 3 is received on front face 21 of rotary shaft 9 and is fixed by aninternal ring 10 b applied against the edge of end 3.

This assembly is shown on FIG. 4.

In a relatively similar manner, end 2 acts with fixed ring 8 receivingend 2 on one of its faces onto which is positioned an internal ring 10 bso as to block it by its edge.

In the example shown, end 2 is situated at the proximal end of thevalve.

The assembly is housed in a body 4, for example made of moulded plasticand closed by a cover 11, preferably equipped with a seal 25 to ensuretight closure of the assembly.

Seal 25 includes a central cut-out to allow the passage of objects andtheir centering.

However, this seal is not perfect and is maximized by the one producedby flexible section 1.

Rotary shaft 9 rotates end 3 of flexible section 1.

This shaft 9 is itself driven by a cable not shown, moved by grippingmeans 14, in this case in the form of a pull-device which is capable ofmoving along the longitudinal axis of the valve.

Gripping means 14 shown on FIGS. 4, 5 and 8 show a part to be gripped bythe user, a fastening zone 19 allowing one end of the cable and anintermediate part equipped with two grooves 16 a, 16 b to be joinedtogether so as to act with slide 15 formed longitudinally on a sidesection of body 4.

The side section constituting the slide may consist of a single part inbody 4 or take the form of an added part.

The slide includes an opening, the longitudinal edges of which allow theengagement of grooves 16 a, 16 b and the sliding movement of grippingmeans 14.

If slide 15 is added to body 4, body 4 has a cut-out 17 allowingassembly of the part forming the slide as can be seen on FIG. 7.

The cable fixed at the level of fastening zone 19 passes through anangle drive shown in the form of pulley 12 turning around a shaft 13shown on FIG. 4.

The angle drive ensures tangential orientation of the cable so that itcan be fixed at rotary shaft 9.

More precisely, shaft 9 has a groove 18 into which the other end of thecable is fastened.

On rotation of shaft 9, the cable winds or unwinds in groove 18.

The end of the cable is fixed in shaft 9 using a pin engaged throughgroove 18, for example by a hole 20.

It is easily understood that when the operator actuates gripping means14 in the longitudinal direction of the valve, traction is applied onthe cable which, by passing over pulley 12, exerts a rotational force onrotary shaft 9 and consequently, end 3 of flexible section 1.

As previously stated, the valve is advantageously configured so as to beclosed by default.

In this context, means for returning to the default sealed position areexecuted.

In the example shown, this consists of a tension spring 24 which isoriented longitudinally in the direction of the valve and receivedaround a guide element 23 in the form of a hollow cylinder with acentral passage.

One of the ends of torsion spring 24 is fixed relative to body 4.

The other end acts in rotation with rotary shaft 9.

As can be seen on FIG. 4, body 4 includes a cavity 7 for receivingtorsion spring 24 and its guide 23.

In addition, the circumference of cavity 7 forms a rotational guidingbody for rotary shaft 9.

As an associated advantage, body 4 can be provided with a side opening6, for example to allow the addition of a fluid such as ananticoagulant, a contrasting or washing medium.

In the example shown, and in particular such as can be seen on FIGS. 4,5 and 10, means are shown for blocking the valve in the open position.Indeed, during a long period of non use, (in particular during storage),it is preferable for flexible section 1 not to be torsionally stressedto avoid its elastic properties deteriorating (in particular sticking ifthe flexible section is in silicone).

In the example shown, the blocking means include a pin 27 that can forma retaining stop for gripping means 14. In the position shown on FIG. 4,flexible section 1 is open whereas torsion spring 24 is tensioned.

It will be noted that the blocking means of the invention can be usedwith various types of rotational actuating means involving a cable or agear system.

According to the example shown, and advantageously, gripping means thatcan operate the actuating means have a displacement which is appreciablyin longitudinal direction 30 of the valve so as to maximize the ergonomyof the assembly. A system for transforming the movement is thus providedbetween gripping means 14 and end 3 which is mobile in rotation. In theexample shown, the system for transforming the movement includes pulley12 and the cable actuating rotary shaft 9. The transformation ofmovement can be produced by other actuating means.

According to the embodiment more precisely shown in FIGS. 11 to 15, asecond cable 32 is created so as to transmit an opposite movement to themovement produced by the transmission cable. Thus, the operator is ableto ensure the return movement of the valve by actuating it in theopposite direction to the first movement. In this case, return spring24, which is present as an option in this case, accompanies the movementinduced by additional cable 32.

Cable 32 has the advantage of ensuring a return to the optimal positionwithout requiring the oversizing of return spring 24, and by counteringany effects due to sticking or remnant deformation of the material usedfor flexible section 1.

From FIG. 11, it will be understood that the additional cable 32, whichis partly illustrated, begins at a seat 40 a or 40 b for fastening theend of the cable on gripping means 14 and passes through return pulley34 and an angle drive pulley common to the transmission cable or coaxialwith it.

The other end of complementary cable 32 is fastened and wound in agroove 33 also formed of a rotary shaft 9. The cables are of coursewound in grooves 18 and 33 so that the rotation of rotary shaft 9simultaneously generates winding up of one and unwinding of the other.

FIG. 15 shows another advantageous characteristic of the invention whichcan be implemented in addition to the preceding characteristics orseparately from them. This characteristic involves the formation of rowsof teeth 35 a, 35 b on each edge of slide 15 in which gripping means 14slide. By forming a finger 36, attached by an elastically deformablezone 37 to gripping means 14, gripping means 14 can be accuratelypositioned and consequently the desired degree of valve opening. Theteeth have a sloping face to allow finger 36 to slide and a verticalface for blocking finger 36.

This toothed system, or another system which blocks gripping means 14,enables the user to apply a high force on the transmission cable (orcomplementary cable 32) and to maintain this force in order to obtainforced torsion of flexible section 1. This can produce a maximum sealeven if the object to be introduced has a variable diameter: as thetorsion is forced, flexible section 1 adapts to any reduction of theobject diameter.

According to a non-illustrated variant, the edges of slide 15 aregraduated or carry quantified indications on the degree of rotation ofmobile end 3 or on the degree of seal. On this latter point, it shouldbe noted that surgical instruments introduced are generally of astandard diameter (in general 3 or 4 different diameters) so that whenthe diameter of the object to be introduced is known the degree of sealcan be deduced (for example expressed in French size) from the positionof gripping means 14 in the slide.

The graduations shown on the slide may however also be limited toidentifying the rotational diameter of mobile end 3. For example, it isuseful to identify at least one rotation of 360°.

It will be noted that the direction of actuation of the gripping meansis not restrictive: according to a first case, means 14 are pushedtowards the distal insertion end in order to open the valve. In a secondcase, pushing closes the valve.

Lastly, stiffener 39 located at proximal end 31 of the instrumentenables the objects to be introduced through the valve by ensuring theirperfect guidance centred on the valve axis.

REFERENCES

-   1. Flexible section-   2. End-   3. End-   4. Body-   5. Tube-   6. Side opening-   7. Cavity-   8. Fixed ring-   9. Rotary shaft-   10 a, 10 b. Internal ring-   11. Cover-   12. Pulley-   13. Shaft-   14. Gripping means-   15. Slide-   16 a, 16 b. Groove-   17. Cut-out-   18. Groove-   19. Securing zone-   20. Hole-   21. Front-   22. Back-   23. Guide-   24. Torsion spring-   25. Seal-   26. Seal-   27. Pin-   28. Knob-   29. Additional valve-   30. Longitudinal axis-   31. Proximal end-   32. Additional cable-   33. Additional groove-   34. Return pulley-   35 a, 35 b. Rows of teeth-   36. Finger-   37. Elastic zone-   38. Leg-   39. Stiffener-   40 a, 40 b. Seat of cable end

1. Valve for surgical or medical instruments comprising: a passage thatcan be at least partially closed by torsional deformation of a flexiblesection (1) of the passage wall, means for rotating a mobile end (3) offlexible section (1) in order to generate torsion, characterized in thatthe actuation means comprise a cable for transmitting movement to themobile end (3) of flexible section (1).
 2. Valve according to claim 1,characterized in that one end of the transmission cable is secured togripping means (14) which can be moved by an operator.
 3. Valveaccording to claim 1, characterized in that it comprises an angle drivedevice to deviate the transmission cable.
 4. Valve according to claim 3,characterized in that the angle drive consists of a pulley (12). 5.Valve according to claim 3, characterized in that the angle drive andgripping means (14) are arranged so that gripping means (14) can bemoved along the longitudinal axis of the valve.
 6. Valve according toclaim 1, characterized in that it has means for returning mobile end (3)to the default position.
 7. Valve according to claim 6, characterized inthat the return means consist of a torsional spring (24) the end ofwhich is fixed and whose other end acts in rotation with mobile end (3)of flexible section (1).
 8. Valve according to claim 6, characterized inthat the return means are arranged so that the passage of the valve isclosed by default.
 9. Valve according to claim 6, characterized in thatit includes means for blocking the valve in the open position.
 10. Valveaccording to claim 9 characterized in that the blocking means include apin (27) blocking the actuating means.
 11. Valve according to claim 1,characterized in that mobile end (3) acts in rotation with a rotationalshaft (9) to which is fastened one end of the transmission cable. 12.Valve according to claim 11, characterized in that rotary shaft (9) hasa groove (18) for fastening and winding up the transmission cable. 13.Valve according to claim 1 including an additional cable (32) which,when pulled, is capable of transmitting a movement to mobile end (3) offlexible section (1) in the opposite direction to that of thetransmission cable.
 14. Valve according to claim 13 in which additionalcable (32) is guided by a return pulley (34) and an angle drive pulley.15. Valve according to claim 13 in which mobile end (3) acts in rotationwith rotary shaft (9) which has a groove (18) for fastening and windingup the transmission cable and an additional groove (33) for fasteningand winding up additional cable (32).
 16. Valve according to claim 2 inwhich gripping means (14) move in a slide (15) the edges of which haveat least one row of teeth (35 a, 35 b) for retaining a finger assembledelastically on the gripping means.
 17. Medical or surgical instrumentcharacterized in that it includes a valve according to claim
 1. 18.Valve according to claim 2, characterized in that it comprises an angledrive device to deviate the transmission cable.
 19. Valve according toclaim 4, characterized in that the angle drive and gripping means (14)are arranged so that gripping means (14) can be moved along thelongitudinal axis of the valve.
 20. Valve according to claim 2,characterized in that it has means for returning mobile end (3) to thedefault position.